MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100— 510(k) K011233

Substantially Equivalent

Apex BioTechnology Corp.

FDA 510(k) clearance K011233 for MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100, Substantially Equivalent on 2001-05-18. Applicant: Apex BioTechnology Corp..

Clearance details

Applicant: Apex BioTechnology Corp.
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 2001-04-23
Decision date: 2001-05-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Edina, MN, US

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Adverse events under product code CGA

product code CGA

Death: 2
Malfunction: 1,816
Total: 1,818

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.